EMEA-001397-PIP05-17 - paediatric investigation plan

Ibrutinib

Key facts

• Invented name:
  • Imbruvica
  • Imbruvica
• Active Substance:
  Ibrutinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0298/2017
• PIP number:
  EMEA-001397-PIP05-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of mantle cell lymphoma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Janssen-Cilag International N.V.

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/10/2017

Decision

P/0298/2017: EMA decision of 4 October 2017 on the granting of a product specific waiver for ibrutinib (Imbruvica) (EMEA-001397-PIP05-17)

Reference Number: EMA/635148/2017